The aim is to create a
high level of multidisciplinary knowledge of the developing CTC (“liquid
biopsy”) field. Based on this, a plan will be defined on how to develop and
integrate CTC diagnostics into routine clinical oncology practice to improve
quality of patient care. This may include partnerships, collaborations, and
research proposals involving both commercial and academic entities.

Scope

Circulating tumor cells
(CTCs) are released from primary and metastatic tumors into the blood and have
high clinical diagnostic potential in oncology, initially most likely within
the context of personalized treatment of patients with metastasized cancer, and
in a later phase potentially extending to early cancer diagnostics.

Treatment of cancer is
expected to change dramatically in the coming years, as an increasing number of
novel targeted drugs, directed at a
biological target in the tumor, will become available and partly replace
standard chemotherapy treatment. With this development metastasized cancer may
be anticipated to turn into a chronic disease where tumor growth can be kept
under control for long periods of time. In this approach, it is necessary to
monitor the effectiveness of the therapy at regular intervals, and this
requires repeated analysis of tumor samples. Unfortunately, while the primary
tumor has in general been surgically removed, most metastatic tumors are
difficult and dangerous to biopsy, especially when this needs to be done
repeatedly. Isolation of CTCs from peripheral blood, as a “liquid biopsy”, is
expected to be able to replace biopsies of metastatic tumors for therapy
guidance.

To date only one
FDA-approved assay (CellSearch from Veridex) is available, the result of which is a CTC-count.
The prognostic value of CTC enumeration using this technique has been well
established in several tumor types. However, this assay is not suited for
prediction of therapy response or resistance, which is expected to become most
important in the near future and requires pathology and molecular diagnostics
to be performed on the CTCs. For these reasons, worldwide efforts are currently
directed at isolating (preferably pure) CTCs from peripheral blood, followed by
dedicated (“single cell”) molecular and pathology diagnostics (similar to tissue
slide diagnostics), and CTC culture for in
vitro determination of drug sensitivity.

The challenge is to
develop further techniques enabling viable CTC isolation from a standard blood
sample, and to process captured CTCs further into “single cell” pathology,
several modalities of molecular diagnostics, and culture. This should
ultimately result in a product/device for CTC diagnostics, suited for easy
routine use in a general hospital setting.

Major
themes and challenges

The following major
themes will be focused on:

1. Clinical perspectives
and requirements for CTC isolation and diagnostics.

2. CTC enrichment and
isolation technologies

3. Single cell
diagnostics: pathology and molecular diagnostics (MDx)

Two minor themes will be
tackled (no full week attendance required):

4. Clinical trials and
regulatory issues

5. Commercialization and
the option of pre-competitive collaboration

Format

The workshop will be
highly interdisciplinary with – mainly scientific – delegates from diverse
fields, among which physicists, chemists, engineers, medical specialists
(oncologists, pathologists), representatives from pharmaceutical,
in-vitro-diagnostics (IVD) and CTC, companies, a regulatory expert anda representative from venture capital (Friday
only). The program will consist of lectures aimed at exchanging knowledge, and
workshops for in-depth discussions and formulating action plans.

Lectures

State-of-the-art
lectures will be given mainly in the morning by key note speakers, who will
introduce the subject from different angles, both technical as well as
clinical, and from the regulatory and business side. They are organized in an
informal setting to be highly interactive, directed at initiating discussion
and exchanging opinions, and for all lectures there will be an equivalent time
for discussion. The intention is to create each day an overview of the theme of
the day as an introduction to afternoon workshops. Together all specialists
present are provided with a broad common background as to potential technical
approaches and the issues to be solved around CTC diagnostics.

Keynote speakers will be
asked to enable active interaction during their presentation, and a moderator
will be present to guide the interactive discussions, keep track of time, and
note down topics that require more detailed discussion after the lecture, or
during one of the dedicated workshops. The participants will be stimulated to
think along with the speaker and participate in the interactive discussions.

Afternoon
workshops

Workshops are dedicated
to both technical as well as clinical and diagnostics topics. Some will focus
on exchanging ideas, experiences, and research results, while other workshops
will aim at obtaining a consensus with respect to experimental approach,
clinical applications, commercialization, and next steps (Friday, final
workshop). Open interdisciplinary communication and discussion is the goal.

Poster
session

The Monday afternoon
(17.00-18.00) session will be dedicated to a poster session with short oral
presentations (3 minutes). If possible posters will be on view all week
starting from the Monday afternoon coffee break

Intellectual
property and confidentiality

The combined
participation of academic and commercial parties has a risk of introducing
issues with regard to intellectual property and confidentiality. However
Lorentz conferences are in essence an academic initiative. Discussions should
be as open as possible and will be summarized in minutes. In case patentable
ideas originate from one of the sessions, inventors and idea will be part of
the minutes.